Expedited safety reporting in drug clinical trials is a regulatory requirement in China that mandates the applicant to timely inform the Center for Drug Evaluation (CDE) when a suspected unexpected serious adverse reaction (SUSAR) event has occurred.
As a more up-to-date reference to drug registration applicants and contract research organizations (CROs) in China, the CDE released the frequently asked questions for expedited reporting of safety data during drug clinical trials (Version 2.0) on March 17, 2023, replacing the previous version issued in April 2019. Both versions were drafted by the CDE in accordance with the Chinese standards and procedures for expedited reporting of safety data during drug clinical trials, and the respective ICH guidelines.
There are a total of 35 questions addressed and being answered in the latest FAQ covering 5 major aspects:
- What should be reported?
- Reporting time frames
- How to report
- Responsible party for expedited reporting, account management and testing related matters
- Other miscellaneous issues
What should be reported?
Scope of drug products
- Traditional Chinese medicines
- Chemical drugs
- Biological products (including vaccines)
Scope of clinical trials
- Phase I clinical trials
- Phase II clinical trials
- Phase III clinical trials
- Bioequivalence trials
- Clinical trials for conditionally approved drugs that need to be completed as required
- Phase IV clinical trials with special requirements in the marketing authorization approval document
Reporting time frames
The applicant should submit the report to the CDE as soon as possible and no later than 7 calendar days after knowing about the fatal or life-threatening SUSAR event. A follow-up report should also be submitted in every 15 calendar days for any new collected information.
How to report
Currently, there are only two types of methods for individual case safety reporting:
- Gateway
- XML file upload
For cases when applicants do not have a pharmacovigilance system in place and unable to use both of the above mentioned methods, applicants can still consider entrusting a third party CRO for reporting. Applicants should keep in mind that the CDE does not accept the submission of CIOMS forms in paper format.
Further information
The FAQ (Version 2.0) further clarifies the SUSAR reporting of combined products and other specific issues.
Read the original CDE announcement (No.17-2023) on the frequently asked questions for expedited reporting of safety data during drug clinical trials (Version 2.0).
Contact Cisema if you would like to learn more about complying with the requirements for pharmaceutical products in China.
